COMPUTER DYNO/GONIO/MYO GRAPHY— 510(k) K942965

Name: FDA 510(k) clearance K942965
Creator: U.S. Food and Drug Administration
Published: 1995-10-07

Substantially Equivalent

Infotronic Medical Engineering

FDA 510(k) clearance K942965 for COMPUTER DYNO/GONIO/MYO GRAPHY, Substantially Equivalent on 1995-10-07. Applicant: Infotronic Medical Engineering. Device class: 2.

Clearance details

Applicant: Infotronic Medical Engineering
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 1994-06-24
Decision date: 1995-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Severna Park, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IKN

view all

K172743 — Natus VikingQuest2017-12-19
K163150 — ViMove22017-07-14
K162383 — Cadwell Sierra Summit, Cadwell Sierra Ascent2017-03-01
K142494 — ViMove2015-05-28
K131094 — VIMOVE2014-07-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.